Bhardwaj Anjali K, Mills Llew, Doyle Michael, Sahid Arshman, Montebello Mark, Monds Lauren, Arunogiri Shalini, Haber Paul, Lorenzetti Valentina, Lubman Dan I, Malouf Peter, Harrod Mary E, Dunlop Adrian, Freeman Tom, Lintzeris Nicholas
Faculty of Medicine, University of Sydney, Camperdown, NSW, Australia.
Drug and Alcohol Services, South East Sydney Local Health District, Sydney, NSW, Australia.
BMC Psychiatry. 2024 Mar 4;24(1):175. doi: 10.1186/s12888-024-05616-3.
Cannabis use disorder (CUD) is increasingly common and contributes to a range of health and social problems. Cannabidiol (CBD) is a non-intoxicating cannabinoid recognised for its anticonvulsant, anxiolytic and antipsychotic effects with no habit-forming qualities. Results from a Phase IIa randomised clinical trial suggest that treatment with CBD for four weeks reduced non-prescribed cannabis use in people with CUD. This study examines the efficacy, safety and quality of life of longer-term CBD treatment for patients with moderate-to-severe CUD.
METHODS/DESIGN: A phase III multi-site, randomised, double-blinded, placebo controlled parallel design of a 12-week course of CBD to placebo, with follow-up at 24 weeks after enrolment. Two hundred and fifty adults with moderate-to-severe CUD (target 20% Aboriginal), with no significant medical, psychiatric or other substance use disorders from seven drug and alcohol clinics across NSW and VIC, Australia will be enrolled. Participants will be administered a daily dose of either 4 mL (100 mg/mL) of CBD or a placebo dispensed every 3-weeks. All participants will receive four-sessions of Cognitive Behavioural Therapy (CBT) based counselling. Primary endpoints are self-reported cannabis use days and analysis of cannabis metabolites in urine. Secondary endpoints include severity of CUD, withdrawal severity, cravings, quantity of use, motivation to stop and abstinence, medication safety, quality of life, physical/mental health, cognitive functioning, and patient treatment satisfaction. Qualitative research interviews will be conducted with Aboriginal participants to explore their perspectives on treatment.
Current psychosocial and behavioural treatments for CUD indicate that over 80% of patients relapse within 1-6 months of treatment. Pharmacological treatments are highly effective with other substance use disorders but there are no approved pharmacological treatments for CUD. CBD is a promising candidate for CUD treatment due to its potential efficacy for this indication and excellent safety profile. The anxiolytic, antipsychotic and neuroprotective effects of CBD may have added benefits by reducing many of the mental health and cognitive impairments reported in people with regular cannabis use.
Australian and New Zealand Clinical Trial Registry: ACTRN12623000526673 (Registered 19 May 2023).
大麻使用障碍（CUD）日益普遍，并导致一系列健康和社会问题。大麻二酚（CBD）是一种无致醉作用的大麻素，因其抗惊厥、抗焦虑和抗精神病作用而闻名，且无成瘾性。一项IIa期随机临床试验的结果表明，用CBD治疗四周可减少CUD患者的非处方大麻使用量。本研究探讨长期CBD治疗对中重度CUD患者的疗效、安全性和生活质量。
方法/设计：一项III期多中心、随机、双盲、安慰剂对照的平行设计试验，对12周疗程的CBD与安慰剂进行比较，并在入组后24周进行随访。将招募250名来自澳大利亚新南威尔士州和维多利亚州七家药物和酒精诊所的中重度CUD成年患者（目标为20%的原住民），他们没有严重的医学、精神或其他物质使用障碍。参与者将每天服用4毫升（100毫克/毫升）的CBD或每3周分发一次的安慰剂。所有参与者将接受四次基于认知行为疗法（CBT）的咨询。主要终点是自我报告的大麻使用天数和尿液中大麻代谢物的分析。次要终点包括CUD的严重程度、戒断严重程度、渴望程度、使用量、戒烟动机和戒断情况、药物安全性、生活质量、身心健康、认知功能以及患者治疗满意度。将对原住民参与者进行定性研究访谈，以探讨他们对治疗的看法。
目前针对CUD的心理社会和行为治疗表明，超过80%的患者在治疗后1至6个月内复发。药物治疗对其他物质使用障碍非常有效，但尚无获批用于CUD的药物治疗方法。由于CBD对该适应症具有潜在疗效且安全性良好，它是CUD治疗的一个有前景的候选药物。CBD的抗焦虑、抗精神病和神经保护作用可能通过减少经常使用大麻者报告的许多心理健康和认知障碍而带来额外益处。
澳大利亚和新西兰临床试验注册中心：ACTRN12623000526673（2023年5月19日注册）
